Effects of liraglutide on pancreatic function in type 2 diabetic patients with secondary failure to oral hypoglycemic agents.

Effects of liraglutide on ß-cell function in type 2 diabetic patients with secondary failure to oral hypoglycemic agents. A randomized, controlled, parallel groups, open-label, phase II study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003335-63-IT

Enrollment

Registered

2012-06-20

Start date

2012-08-22

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: VICTOZA*SC 2PEN 3ML 6MG/ML Pharmaceutical Form: Solution for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • The subject must give signed informed consents before any trial-related activities. • Type 2 diabetic subjects • Age >30 years and 25 Kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Participation in any other clinical trial three month prior to trial entry • Pregnancy, breastfeeding or women of childbearing age who do not follow adequate contraception • Patients has taken other antidiabetic drugs in the three month prior to trial entry • Current systemic treatment with concomitant medication having a significant influence on an end-point e.g. corticosteroids, thiazides, ß-blockers or ACE-inhibitors. • Known or suspected history of drug or alcohol dependence. • Any other significant concomitant disease such as cardiovascular (heart failure, angina pectoris, recent (within the last 12 months) myocardial infarction) or symptomatic peripheral vascular disease, malignant, hepatic disease (ALT>2 times upper limit of normal), renal impairment (serum creatinine >1.5 mg/dl). • Known or suspected allergy to trial products • BMI =25 Kg/m2 or =40 Kg/m2 • Mental incapacity • Any disease or condition which the investigator feels would interfere with the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine to which extent liraglutide can maintain ß-cell function in type 2 diabetic patients with secondary failure after an adequate period of good glycaemic control.;Secondary Objective: To compare the effects of liraglutide and sulphonylurea on glicaemic control (fasting plasma glucose, HbA1C).;Primary end point(s): ß-cell glucose sensitivity as derived from the OGTT test analyzed according to Mari et al.;Timepoint(s) of evaluation of this end point: at 64 and 66 weeks	—

Measure

Time frame

Main Objective: To determine to which extent liraglutide can maintain ß-cell function in type 2 diabetic patients with secondary failure after an adequate period of good glycaemic control.;Secondary Objective: To compare the effects of liraglutide and sulphonylurea on glicaemic control (fasting plasma glucose, HbA1C).;Primary end point(s): ß-cell glucose sensitivity as derived from the OGTT test analyzed according to Mari et al.;Timepoint(s) of evaluation of this end point: at 64 and 66 weeks

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Secondary

Measure	Time frame
Secondary end point(s): parameters of glycaemic control (FPG, HbA1C), time of loss of glycaemic control after stopping insulin treatment and proxies of beta-cell function i.e. Rate sensitivity (referring to the magnitude of beta-cell to respond to changes in prevailing plasma glucose concentrations), Potentiation factor, Dose response Insulin Secretion Rate and HOMA-B;Timepoint(s) of evaluation of this end point: at 64 and 66 weeks	—

Measure

Time frame

Secondary end point(s): parameters of glycaemic control (FPG, HbA1C), time of loss of glycaemic control after stopping insulin treatment and proxies of beta-cell function i.e. Rate sensitivity (referring to the magnitude of beta-cell to respond to changes in prevailing plasma glucose concentrations), Potentiation factor, Dose response Insulin Secretion Rate and HOMA-B;Timepoint(s) of evaluation of this end point: at 64 and 66 weeks

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Countries

Italy

Contacts

Public ContactU.O. DIABETOLOGIA E MAL.METABOLICHE

UNIVERSITA' DI PISA

stefano.delprato@med.unipi.it+39050995103

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026